“Rising clinical trial costs and the continued high failure rates in
Phase III have forced pharmaceutical companies to reevaluate how they
conduct their clinical development,” explained Andrew Schafer, President
of ISR. “Pharma is looking across their entire R&D process for ways to
improve outcomes and adaptive trial designs are definitely in the mix,
as we’ve seen an increase in the adoption of adaptive trials since ISR
last examined the topic in 2010.”

ISR’s new adaptive trial report is based on a survey of 102
pharmaceutical decision-makers who have experience with adaptive trials.
The report analyzes the current market dynamics, including the levels of
adoption, the types of studies being conducted, the reasons why these
trials are gaining momentum, the major drivers for adoption, and the
barriers that decision makers are likely to face when instituting
adaptive design strategies.

“ISR found that 91% of respondents indicated adaptive trials are gaining
momentum within their organizations,” Schafer explained. “Respondents
indicated their companies are implementing these strategies to reach
‘go/no go decisions’ faster and hoping that adaptive trials will
increase the likelihood of identifying the correct dosage to move
forward with into Phase III trials.”

The report also examines the outsourcing environment surrounding
adaptive clinical trials by analyzing the current level of outsourcing
penetration, quantifying sponsors’ comfort level associated with
outsourcing adaptive activities, as well as identifying criteria
sponsors use to identify and select service providers.

“When conducting a clinical development study with an adaptive design,
sponsors are more comfortable outsourcing the clinical operations
component compared to the statistical design component,” Schafer
explained. “One component that sponsors remain unlikely to outsource is
regulatory planning.”

About Industry Standard Research

Industry Standard Research is the premier, full service market research
provider to the pharma and pharma services industries. With over a
decade of experience, ISR delivers an unmatched level of domain
expertise. For more information about ISR’s off-the-shelf intelligence
and custom research offerings, please visit the company’s Web site at www.ISRreports.com,
email info@ISRreports.com, or
follow us on Twitter @ISRreports.